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Prolensa

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Prolensa

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Method of action: Anti-Inflammatory, Nonsteroidal Anti-Inflammatory, Ophthalmologicals

Treatment option: Pain, Cataract, Surgery

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Prolensa

What is Prolensa? Defining the Bromfenac Ophthalmic Solution

Property Description
Active ingredient Bromfenac (as sodium sesquihydrate)
Form Ophthalmic solution (sterile eye drops)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Reduction of pain and inflammation in the eye
Origin Synthetic chemical compound

Defining Prolensa: Identity, Form, and Composition

Prolensa is a prescription-only medicine presented as a sterile ophthalmic solution delivered via the topical ophthalmic route, specifically designed for use in the eye. The active chemical entity responsible for the drug’s effects is Bromfenac sodium sesquihydrate, a potent compound provided as an aqueous solution. This formulation focuses solely on the Bromfenac substance to achieve its therapeutic outcome, delivered directly to the target tissue as eye drops. Prolensa is often recognized for its convenience among ophthalmic NSAIDs, a feature frequently noted in pharmacological studies.

Pharmacological Classification: Bromfenac as an NSAID

The pharmacological identity of Bromfenac within Prolensa classifies it as a Nonsteroidal Anti-inflammatory Drug (NSAID), a category of medication that targets inflammation without using steroids. As a synthetic compound, Bromfenac belongs to the arylcarboxylic acid group, and its core action is to function as a potent Cyclooxygenase inhibitor. This classification is clinically recognized for providing effective anti-inflammatory action and is a cornerstone in managing postoperative ocular discomfort.

General Therapeutic Purpose and Anti-inflammatory Action

The primary function of this NSAID ophthalmic solution is to manage and reduce ocular discomfort, a typical use scenario being the mitigation of pain and swelling following cataract surgery. This therapeutic effect is primarily driven by its ability to block the biosynthesis of prostaglandins, the chemical messengers that generate swelling and pain signals in ocular tissues. In essence, the medicine is designed to temper the inflammatory cascade that may follow a procedure, thereby reducing associated irritation and tenderness in the eye.

What side effects are possible with Prolensa?

Possible Side Effects and Safety Information

The safety profile of Prolensa (bromfenac ophthalmic solution) is based on adverse reactions and safety constraints documented in official government regulatory documents. As an ophthalmic Nonsteroidal Anti-inflammatory Drug (NSAID), the most common adverse reactions are typically associated with the ocular system.

Officially Classified Adverse Reactions

The most commonly reported adverse reactions, observed in 3% to 8% of patients during clinical trials, are anterior chamber inflammation, a foreign body sensation in the eye, eye pain, photophobia (light sensitivity), and vision blurred. Less frequently, headache has been reported.

System-Organ Class Examples of Documented Adverse Reactions
Eye disorders Anterior chamber inflammation, foreign body sensation, eye pain, vision blurred, keratitis, corneal erosion, corneal perforation.
Nervous System Headache
Immune System Allergic-type reactions, including asthmatic episodes (due to sodium sulfite content).

Serious Ocular and Systemic Safety Concerns

The use of topical NSAIDs, including this medicine, is associated with the potential for serious ocular events that may be sight threatening. These include corneal thinning, corneal ulceration, and corneal perforation. The risk and severity of these adverse events are noted to increase with use extending beyond 14 days post-surgery or in specific patient populations.

Safety Constraints and Population Risk

Certain groups are listed as having an increased risk for corneal adverse events, including patients with diabetes mellitus, rheumatoid arthritis, ocular surface diseases, or a history of complicated ocular surgeries. Additionally, the NSAID class of drugs can cause slow or delayed healing and has the potential to cause increased bleeding time in ocular tissues.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory guidance for Prolensa (bromfenac ophthalmic solution) focuses on the low systemic exposure associated with its topical, ophthalmic route of administration.

Exposure Type Official Regulatory Statement
Topical Over-administration The regulatory profile states that over-administration of drops into the eye is not expected to be dangerous. This is based on the low concentration of the active ingredient and the limited capacity of the eye to retain excess solution, which causes it to wash out.
Accidental Oral Ingestion This is the primary overdose concern documented in official labeling. Ingestion of the entire bottle contents (5 mL) represents a very low total dose of bromfenac, significantly below historical oral dosing levels of the compound.

Required Emergency Actions and Management

Regulatory authorities mandate specific actions if the solution is swallowed:

  • When to Seek Help: In the event of known or suspected accidental oral ingestion, it is required to seek emergency medical attention immediately or to call a Poison Help line.
  • Antidote and Treatment: The official prescribing information confirms that no specific antidote is known for bromfenac overdose. Therefore, clinical management is designated as symptomatic and supportive treatment. A supportive procedural step listed in some regulatory documents is the administration of fluids to dilute the medicinal product following accidental ingestion.

This profile is defined by the product's classification as a low-risk topical agent, with emergency action strictly mandated for the potential systemic exposure risk presented by oral ingestion.

Therapeutic Uses of Prolensa

Quick Facts

  • Indication: Treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Therapeutic Uses and Benefits

Prolensa is an approved ophthalmic solution for individuals who have had cataract surgery. Its primary function is the treatment of postoperative inflammation and the reduction of ocular pain associated with this type of eye surgery. By addressing these post-surgical symptoms, it helps to support patient comfort and recovery during the healing period.

The medication is a nonsteroidal anti-inflammatory drug (NSAID) that acts locally in the eye. Using Prolensa as directed can lead to a greater proportion of patients achieving complete clearance of ocular inflammation by Day 15, and a higher rate of patients reporting being pain-free at Day 1 after surgery, compared to a placebo. The approved course of treatment is designed for short-term use following the procedure to manage discomfort and swelling.

Eligibility and Restrictions for Use

Who Can and Cannot Use Prolensa?

This section outlines the population eligibility rules for Prolensa (bromfenac ophthalmic solution) as strictly defined by regulatory authorities.

Populations for Whom Use is Established

Adults (18 years of age and older) who have undergone cataract surgery are the established population for this medicine. Use is also permitted in older adults/geriatric patients, as no differences in safety or effectiveness have been observed compared to younger adults.

Populations for Whom Use is Prohibited or Restricted

Use is contraindicated in patients with a known hypersensitivity to bromfenac or any component of the formulation. The medicine is also contraindicated for those with known cross-sensitivity to acetylsalicylic acid (Aspirin), phenylacetic acid derivatives, or other NSAIDs.

Safety and efficacy have not been established in pediatric patients (below the age of 18 years), defining a non-eligible age group.

Conditional Use and Restricted Populations

Use should be avoided in late pregnancy (from 30 weeks gestation) and requires caution during other stages of pregnancy and for nursing mothers. The regulatory label recommends use with caution for patients with a known tendency to bleed and those with conditions that increase the risk of corneal adverse events, such as diabetes mellitus and rheumatoid arthritis. Prolensa should not be instilled while wearing contact lenses.

What should I know about interactions with other medicines?

The official regulatory profile for Prolensa (Bromfenac ophthalmic solution) highlights interactions that are primarily localized or pharmacodynamic, reflecting the drug's topical administration and negligible systemic exposure.

Systemic drug-drug interactions involving metabolic enzymes, such as CYP2C9, are officially noted as unlikely to be clinically relevant due to the low plasma concentrations achieved.

Documented Interaction Patterns

Classification Official Regulatory Finding
Pharmacodynamic Interaction Co-administration with topical corticosteroids may increase the potential for slowed or delayed ocular healing.
Bleeding Risk There is an increased theoretical risk of ocular tissue bleeding when used concurrently with systemic medications that prolong bleeding time, such as anticoagulants.
Timing-based Rule Other topical ophthalmic medications must be administered at least five (5) minutes apart from Prolensa to prevent dilution or washout.
Procedural Restriction Soft contact lenses must be removed before use; they may be reinserted 10 minutes after instillation due to the preservative Benzalkonium Chloride.

Summary of Regulatory Context

The interaction structure focuses on precautionary co-administration rather than contraindications. The profile does not contain specific restrictions regarding food, alcohol, or herbal products, nor does it specify unique interaction guidance for particular patient populations like the elderly or those with hepatic impairment.

Mechanism of Action

The pharmacological action of Prolensa is defined by its role as a non-selective inhibitor of the cyclooxygenase (COX) enzymes, targeting both COX-1 and COX-2 isoforms present in ocular tissues. This direct, competitive interaction blocks the active site of the enzymes, thereby preventing the conversion of arachidonic acid into prostaglandins. This enzymatic arrest suppresses the initial step of the eicosanoid signaling cascade. The consequence of this blockade is the biochemical stabilization of local processes in the eye. Limiting prostaglandin synthesis modifies the effects of increased eicosanoid mediator activity, resulting in reduced chemical output within the affected pathways. This mechanism contributes to the development of decreased vascular permeability and reduced nerve responsiveness in the ocular tissues.

Dosage and Administration Information

How to Use Prolensa: Official Administration Guidelines

The administration protocol for Prolensa (bromfenac ophthalmic solution 0.07%) defines its use as a topical ophthalmic medication delivered directly to the eye surface.

Key Administration Parameters

Instruction Entity Official Administration Guidelines
Route of Administration Topical ophthalmic route, delivered as a solution directly to the eye.
Standard Dosing Schedule One drop of the 0.07% ophthalmic solution administered to the affected eye once daily.
Course Duration A fixed course of 16 days total: beginning one day prior to cataract surgery, continuing on the day of surgery, and for the subsequent 14 days postoperatively.
Special Procedural Conditions When used with other topical eye drops, a minimum interval of 5 minutes must separate the application of each medication. Contact lenses must be removed prior to application and can be reinserted 10 minutes after the dose.
Age-Group Rules Safety and effectiveness are not established for pediatric patients under the age of 18; no specific dose adjustment is reported for older adults.

Connection to the Overall Use Protocol

The official instructions define a highly specific and time-bound therapeutic regimen. This protocol establishes the once-daily, one-drop dose as the standardized application method, linked precisely to the 16-day period surrounding the surgical procedure. This defined structure mandates specific procedural actions—such as timing drops relative to other medicines and managing contact lens use—to ensure the standardized delivery of the solution.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Prolensa

The key research data comes from short-term research contexts involving patients who have undergone routine cataract surgery. The studies were designed to examine measurement patterns in two areas: outcomes linked to inflammatory or irritative states and patient-reported outcomes describing perceived discomfort. Research does not determine whether an individual will respond similarly; study results reflect the specific conditions under which they were conducted.

Evidence for Use Following Cataract Surgery

The core research involved multiple large-scale studies where participants were randomly assigned to receive either Prolensa or a vehicle following routine cataract surgery. This approach, a randomized, double-masked clinical trial, is used in research exploring how outcomes related to physical discomfort and inflammatory responses change over time.

Research was conducted to explore patterns in post-operative symptoms, and findings describe the patterns observed in the studies related to specific, predefined clinical outcomes.

Studies on Inflammation Clearance and Pain Status

Studies explored how the inflammatory status, measured by counting cells and observing flare, evolved in the observed populations over a defined time interval. The trials examined the proportion of patients who had complete clearance of inflammation, meaning a measurement score of zero. Additionally, these trials evaluated the proportion of patients with a score of zero for ocular pain at various post-operative checkpoints.

Summary of Evidence Gaps and Uncertainty

The duration of the main clinical studies was limited, typically extending only for a few weeks post-surgery. Therefore, long-term effects are not fully established. The research was primarily derived from studies including adult patients who underwent uncomplicated cataract removal. Data for certain groups remain insufficient, as the research does not include adequate information about the use of Prolensa in children or pediatric populations. Limited information is also available for patients with complicated surgical procedures or pre-existing severe ocular conditions.

Frequently Asked Questions (FAQ)

Common questions about Prolensa (FAQ)

Q: What is the active ingredient in Prolensa?

The active ingredient in Prolensa is bromfenac. This is classified as a nonsteroidal anti-inflammatory drug, or NSAID. According to official product information, bromfenac works to reduce inflammation in the eye.

Q: What is Prolensa used for?

Prolensa is officially indicated to treat non-infectious inflammation of the eye (ocular inflammation). Specifically, regulatory documents state it is approved for use following cataract surgery. Its purpose is to help manage the swelling and discomfort that may occur after the procedure.

Q: How long should I use Prolensa after my surgery?

Studies and official information indicate that Prolensa is typically used for a short duration following cataract surgery. The authorized treatment length is generally up to 14 days post-surgery. The precise duration is determined by your prescribing healthcare provider.

Q: Can I use Prolensa for other types of eye inflammation?

According to the official product information, Prolensa is only indicated for treating inflammation that occurs after cataract surgery. The regulatory approval is specific to this condition. It has not been studied or approved for treating other types of eye inflammation or pain outside of this specific indication.

Q: Does Prolensa contain preservatives?

Regulatory documents state that Prolensa does contain a preservative called benzalkonium chloride. Preservatives are included in the formulation to help keep the medication sterile and prevent the growth of germs. If you have known sensitivities to this ingredient, review the full product information or consult a healthcare professional.

Q: Is Prolensa an antibiotic?

No, Prolensa is not an antibiotic. The active ingredient, bromfenac, is an NSAID (nonsteroidal anti-inflammatory drug), which means it primarily works by reducing inflammation and swelling. It is not used to treat or prevent bacterial infections.

Q: How should Prolensa be stored?

According to the official product information, you should store Prolensa at room temperature, ideally between 15 C and 25 C (59 F and 77 F). It must be kept out of the reach of children. The bottle should be kept with the cap tightly closed when not in use.

How should Prolensa be stored and disposed of?

The storage and disposal of Prolensa (bromfenac ophthalmic solution) are strictly governed by regulatory requirements to ensure product quality and sterility.

Storage & Disposal Scope

Requirement Official Regulatory Statement
Labeled storage temperature Store at Controlled Room Temperature (15°C to 25°C or 59°F to 77°F).
Light/moisture protection Store away from moisture, direct light, and excessive heat.
Stability after opening Discard any unused eye drops 28 days after opening (some labels state to throw away the bottle after your treatment is finished).
Handling requirements Keep from freezing. The bottle cap must be replaced after using.
Packaging-related rules Store in a closed container and keep the container tightly closed. Do not touch the applicator tip to any surface to avoid contamination.
Disposal instructions Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how to dispose of unused medicine.
Child-protection storage Must be stored out of the reach of children.

Connection to the overall storage/disposal profile: Regulatory documents mandate that Prolensa be stored at a defined room temperature and protected from environmental factors like freezing, light, and heat to ensure stability. Handling rules emphasize maintaining sterility by keeping the container tightly closed and avoiding tip contamination. The official instructions require consulting a professional for discarding unused product and mandate proper disposal of the bottle after the designated use period.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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